Frailty Assessment and Treatment Strategies in the Elderly at Risk of Functional Decline in the Community
NCT ID: NCT03591055
Last Updated: 2022-09-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
300 participants
INTERVENTIONAL
2018-08-01
2021-12-31
Brief Summary
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Detailed Description
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Design: Study in two phases: a qualitative study to develop the intervention and a randomized clinical trial with parallel arms and control group.
Intervention: Participants in the control group will receive the usual standard care and regular referrals. Patients in the intervention group will be first derived to a nurse case manager for initial application of a comprehensive geriatric assessment (CGA). Then patient-centered interventions will be prescribed, according to the different target areas identified in the geriatric assessment, along with medication review, aerobics exercise plan and memory workshops following the model adapted in Phase I.
After 3 and 18 months, measures of functional and cognitive performance, quality of life, frailty, adverse outcomes (institutionalization, hospitalization, death) and health care costs will be collected.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Intervention Group
Patients in the intervention group will be first derived to a nurse case manager for initial application of a comprehensive geriatric assessment. Then patient-centered interventions will be prescribed, according to the different target areas identified in the geriatric assessment. All participants in the intervention group will undergo a medication review and will also perform an aerobics exercise plan in the primary care centre, 60-minute session twice a week on non-consecutive days for 6 weeks (12 sessions of 60 minutes each) and memory workshops (10 sessions).
CGA, medication review, exercise and cognitive stimulation
Comprehensive geriatric assessment. Patient-centered interventions according to the different target areas identified in the geriatric assessment. Medication review. Groupal Exercise plan and memory workshops.
Control group
Participants in the control group will receive the usual standard care and regular referrals.
No interventions assigned to this group
Interventions
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CGA, medication review, exercise and cognitive stimulation
Comprehensive geriatric assessment. Patient-centered interventions according to the different target areas identified in the geriatric assessment. Medication review. Groupal Exercise plan and memory workshops.
Eligibility Criteria
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Inclusion Criteria
* Positive screen with Gerontopole screening tool and/or RISC tool
Exclusion Criteria
* Advanced conditions with short life expectancy
* Severe disability
* Severe Dementia
65 Years
ALL
No
Sponsors
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Institut Català de la Salut
OTHER
Instituto de Salud Carlos III
OTHER_GOV
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
OTHER
Responsible Party
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Principal Investigators
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FRANCISCO Orfila Pernas
Role: PRINCIPAL_INVESTIGATOR
Institut Catala de Salut
Locations
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IDIAP JGol
Barcelona, , Spain
Countries
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Other Identifiers
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PI16/01683
Identifier Type: -
Identifier Source: org_study_id
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